[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3880]

[Page 369]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874_EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 874.3880  Tympanostomy tube.

    (a) Identification. A tympanostomy tube is a device that is intended 
to be implanted for ventilation or drainage of the middle ear. The 
device is inserted through the tympanic membrane to permit a free 
exchange of air between the outer ear and middle ear. A type of 
tympanostomy tube known as the malleous clip tube attaches to the 
malleous to provide middle ear ventilation. The device is made of 
materials such as polytetrafluoroethylene, polyethylene, silicon 
elastomer, or porous polyethylene.
    (b) Classification. Class II.